| | Class 2 Device Recall Pointe Scientific |  |
| Date Initiated by Firm | June 12, 2006 |
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| Date Posted | August 30, 2006 |
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| Recall Status1 |
Terminated 3 on November 19, 2007 |
| Recall Number | Z-1458-06 |
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| Recall Event ID |
35497 |
| 510(K)Number | K992002 |
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| Product Classification |
Cholesterol Reagent Set - Product Code CCH
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| Product | Auto HDL reagent, sold by Pointe Scientific; Catalog no. 3-H7545-L . |
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| Code Information |
Lots 523002, exp. 2/07, and 531801, exp. 2/07. |
Recalling Firm/
Manufacturer |
Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188-2261
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| For Additional Information Contact |
734-487-8300 |
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Manufacturer Reason
for Recall | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. |
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FDA Determined
Cause 2 | Other |
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| Action | Consignees were notified via recall letter dated 6/12/06 to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International accounts were notified via email. |
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| Quantity in Commerce | To be determined |
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| Distribution | Worldwide-USA and Greece, India, Korea, Lebanon, Pakistan, Poland, Singapore, Trinidad, Turkey, United Arab Emirates and Venezuela. |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = CCH
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